Consulting Services

Strategic Clinical Development Support for U.S. and Global Sponsors

Wakefield Clinical Research provides strategic and operational consulting services to biotechnology, pharmaceutical, and medical device companies developing clinical programs in the United States.

Our team combines clinical development expertise with hands-on experience in clinical operations, regulatory affairs, quality assurance, and investigative site execution.

Clinical Development & Operations Consulting

Clinical development strategy
Protocol design and review
Study feasibility assessment
U.S. operational strategy
Site and enrollment strategy
CRO and vendor selection
Study rescue and operational troubleshooting
Sponsor oversight strategy

Regulatory Affairs Consulting

U.S. regulatory strategy
Development pathway assessment
Regulatory gap analysis
IND strategy and readiness
FDA meeting strategy
Protocol and informed consent review
Regulatory issue resolution

Quality & Compliance Consulting

Quality system assessment
QMS and SOP development
GCP compliance strategy
Audit and inspection readiness
CAPA strategy and remediation
Vendor qualification and oversight
Clinical quality risk assessment

Practical, Senior-Level Guidance

Wakefield provides direct access to experienced clinical development professionals who understand both sponsor expectations and the realities of study execution. Our consulting support can be provided for a specific challenge, a development milestone, or throughout a clinical program.

For international sponsors, Wakefield also provides U.S.-based clinical development support with bilingual English and Chinese communication capabilities.

Planning a U.S. clinical development program? Contact Wakefield Clinical Research to discuss your program and consulting needs.